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Article Modular Manufacturing Platforms for Biologics
May 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 5 It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…

Article Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors review efforts to limit polymer degradation without significantly impeding cell growth. Jan 01, 2015 By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Her…

Article Improving PAT for Biologics
The complexity of biopharma processes requires innovative solutions. Dec 01, 2014 By Cynthia Challener, PhD BioPharm International A key component of the quality-by-design (QbD) ap…

Article Trends in Single-use Bioreactors
Representatives from industry supplier companies address innovations, reliability, barriers to adoption, and the role of singIe-use bioreactors in bioprocessing. By: Randi Hernandez Whil…

Article Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment. A critical quality attribute (CQA) has been defined as “a physical, chemical, …

Article 2014 Manufacturing Trends and Outlook
Single-use systems and other technologies drive process efficiencies, but there is room for improvement. In a recent survey of current trends and practices in biopharmaceutical manufacturing…

Article Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Report from the Lanzarote meeting May 13th – 17th, 2013 Yet another well-attended and successful Plasma Product Biotechnology (PPB) meeting has been held. The meeting focu…

Article Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology. By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…

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